Trial · NCT07881016
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of participants in each transdiagnostic subgroup defined by social withdrawal and anhedonia. | Baseline (Visit 1) | Participants are classified into mutually exclusive subgroups by unsupervised clustering of standardised scores from: Snaith-Hamilton Pleasure Scale (SHAPS; 0-14, higher = greater anhedonia); Self-evaluation of Negative Symptoms social withdrawal subscale (SNS; 0-8, higher = greater social withdrawal); UCLA Loneliness Scale v3 (20-80, higher = greater loneliness); Behavioral Activation System scales of the BIS/BAS questionnaire (13-52, higher = greater approach motivation); and percentage of optimal choices in the Reward Probabilistic Learning Task (0-100%, higher = better reward learning). The outcome is the percentage of participants assigned to each subgroup. Subgroups are then characterised by clinical, genetic, blood biomarker and brain MRI data (secondary outcomes). |
| Secondary | Proportion of participants in each subgroup defined by cognitive flexibility, neurodevelopment, sensory processing, sleep and impulsivity | Baseline (Visit 1) | Participants are classified into mutually exclusive subgroups by unsupervised clustering of standardised scores from: CANTAB Intra-Extra Dimensional Set Shift adjusted total errors (cognitive flexibility; higher = worse); neurological soft signs total score (higher = more signs); sensory processing questionnaire total score (higher = more sensory abnormalities); Insomnia Severity Index (0-28, higher = more severe insomnia); Hypersomnia Severity Index (0-36, higher = more severe hypersomnolence); Epworth Sleepiness Scale (0-24, higher = more daytime sleepiness); and Barratt Impulsiveness Scale version 11 (30-120, higher = more impulsivity). The outcome is the percentage of participants assigned to each subgroup. |
| Secondary | Prevalence of autoimmune psychosis, metabolic abnormalities and genetic abnormalities within identified subgroups | Baseline (Visit 1) | Proportion of participants with: autoimmune psychosis (clinical criteria such as abrupt onset, minor neurological signs, catatonia, treatment resistance, and presence of anti-neuronal autoantibodies); metabolic abnormalities (type 2 diabetes, obesity, metabolic syndrome, lipid disorders, mitochondrial and inflammatory abnormalities, assessed by anthropometric measures and blood tests); and genetic abnormalities (genetic sequencing). |
| Secondary | Hippocampal volume measured by 3T brain MRI in patients and healthy volunteers | Visit 2, within 6 weeks of Visit 1 | Hippocampal volume (mm3) measured by structural 3T MRI, reported for healthy volunteers, all patients, and patients by diagnostic category. |
| Secondary | Plasma high-sensitivity C-reactive protein concentration in patients and healthy volunteers | Baseline (Visit 1) | Fasting plasma high-sensitivity C-reactive protein concentration (mg/L), reported for healthy volunteers, all patients, and patients by diagnostic category. |
| Secondary | Polygenic risk score for schizophrenia in patients and healthy volunteers | Baseline (Visit 1) | Polygenic risk score for schizophrenia (standardised units, z-score) computed from genome-wide genotyping data, reported for healthy volunteers, all patients, and patients by diagnostic category. Higher scores indicate greater genetic liability. |
| Secondary | Number of multimodal participant clusters identified by unsupervised clustering of all collected data | From baseline (Visit 1) | Unsupervised clustering after dimensionality reduction (e.g., principal component analysis) applied to all collected variables (clinical scales, cognitive tests, digital data, environmental data, omics and brain MRI). The optimal number of clusters is selected using internal validation indices (e.g., silhouette coefficient). The outcome is the number of distinct clusters identified. |
| Secondary | Percentage of participants assigned to a different subgroup at 1-year follow-up compared with baseline | From baseline (Visit 1) to 1-year follow-up (Visit 3, 12 to 14 months after Visit 1) | The subgroup classification used for the primary outcome (clustering of social withdrawal and anhedonia scores) is repeated at 1-year follow-up. The outcome is the percentage of participants assigned to a different subgroup at Visit 3 than at Visit 1. |
| Secondary | Long-term treatment response measured by the Alda scale total score | 1-year follow-up (Visit 3) | Clinician-rated Retrospective Criteria of Long-Term Treatment Response (Alda scale). Total score ranges from 0 to 10; higher scores indicate better treatment response. |
| Secondary | Global functioning measured by the Global Assessment of Functioning (GAF) score. | Baseline (Visit 1) and 1-year follow-up (Visit 3) | Clinician-rated Global Assessment of Functioning scale. Score ranges from 1 to 100; higher scores indicate better psychological, social and occupational functioning. |
| Secondary | Percentage of patients with a psychiatric relapse during follow-up | From baseline (Visit 1) to 1-year follow-up (Visit 3) | Relapse defined as the occurrence of at least one mood episode, psychotic episode or psychiatric hospitalisation between Visit 1 and Visit 3, assessed by clinical interview. |
| Secondary | Percentage of participants with a new medical comorbidity during follow-up | From baseline (Visit 1) to 1-year follow-up (Visit 3) | New-onset medical comorbidity (e.g., diabetes, hypertension, dyslipidaemia, obesity) between Visit 1 and Visit 3, assessed by medical questionnaire and routine blood tests. |
| Secondary | Household crowding index in successive residences over the lifetime. | Baseline (Visit 1) | Mean number of occupants per room across successive residences from the prenatal period to inclusion, collected by residential history questionnaire. Higher values indicate greater crowding. |
| Secondary | Number of residential moves over the lifetime | Baseline (Visit 1) | Number of changes of residence from the prenatal period to inclusion, collected by residential history questionnaire. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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